Squamous Cell Carcinoma of the Anal CanalPhase 3NCT04472429
Carboplatin-paclitaxel With Retifanlimab or Placebo in Participants With Locally Advanced or Metastatic Squamous Cell Anal Carcinoma (POD1UM-303/InterAACT 2).
A Phase 3 study testing carboplatin, paclitaxel and retifanlimab in people with Squamous Cell Carcinoma of the Anal Canal, run by Incyte Corporation at 84 sites in 13 countries.
Trial summary
This study is a Phase 3 global, multicenter, placebo-controlled double-blind randomized study that will enroll participants with inoperable locally recurrent or metastatic SCAC not previously treated with systemic chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of the Anal Canal
- What is being tested?
- carboplatin, paclitaxel and retifanlimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 308 participants
- Where
- 84 sitesin 13 countries
- Study dates
- 9 Nov 2020to 26 Sep 2025
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to comprehend and willing to sign a written ICF for the study.
- Are 18 years of age or older (or as applicable per local country requirements).
- Histologically or cytologically verified, inoperable locally recurrent or metastatic SCAC.
- No prior systemic therapy other than the following: a. Chemotherapy administered concomitantly with radiotherapy as a radiosensitizing agent is permitted.
- Prior neoadjuvant or adjuvant therapy if completed ≥ 6 months before study entry.
- Has measurable disease per RECIST v1.1 as determined by local site investigator/radiology assessment. Tumor lesions situated in a previously irradiated area, or in an area subjected to other loco-regional therapy, are usually not considered measurable unless there has been demonstrated progression in the lesion.
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- Able and willing to provide adequate tissue sample and whole blood sample with central testing result prior to randomization. Biopsy for archival samples should have occurred within 9 months prior to randomization.
- ECOG performance status 0 to 1.
- If HIV-positive, then must be stable as defined by: a. CD4+ count ≥ 200/μL, b. Undetectable viral load per standard of care assay, c. Receiving antiretroviral therapy (ART/HAART) for at least 4 weeks prior to study enrollment, and have not experienced any HIV-related opportunistic infection for at least 4 weeks prior to study enrollment.
- Willingness to avoid pregnancy or fathering children
Who cannot join
- Has received prior PD-(L)1 directed therapy
- Has received prior radiotherapy with or without radiosensitizing chemotherapy within 28 days of Cycle 1 Day 1 except for palliative radiation (30 Gy or less) which is restricted for 14 days of Cycle 1 Day 1 (note: all toxicities associated should have resolved to Grade ≤ 1).
- Participants with laboratory outside of the protocol defined ranges.
- History of second malignancy within 3 years (with exceptions).
- Clinically significant pulmonary, cardiac, gastrointestinal or autoimmune disorders.
- Active bacterial, fungal, or viral infections, including hepatitis A, B, and C and IV antibiotic use within 7 days of Cycle 1 Day 1.
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- Receipt of a live vaccine within 28 days of planned start of study therapy.
- History of organ transplant, including allogeneic stem cell transplantation.
- Known active CNS metastases and/or carcinomatous meningitis.
- Known hypersensitivity to platinum, paclitaxel, another monoclonal antibody, or any of the excipients that cannot be controlled with standard measures (eg, antihistamines, corticosteroids).
- Participant is pregnant or breastfeeding.
- Current use of protocol defined prohibited medication.
- Has pre-existing peripheral neuropathy that is ≥ Grade 2 by CTCAE v5.
- Inability or unlikely, in the opinion of the investigator, to comply with the Protocol requirements
Trial locations and contacts
84 sites in 13 countries.
84 sites in 13 countries
France15 sites
Institut de Cancerologie de L Ouest - Site Paul Papin
Angers, 49055
Chu Besancon Hospital Jean Minjoz
Besançon, 25030
Centre Hospitalier Universitaire de Bordeaux
Bordeaux, 33075
Centre Leon Berard
Lyon, 69008
Chu Hopital de La Timone
Marseille, 13385
Institut Du Cancer de Montpellier
Montpellier, 34298
Centre Antoine Laccassagne
Nice, 06200
Hospital Universitaire Pitie-Salpetriere
Paris, 75651
Hospital de La Miletrie
Poitiers, 86021
Chu de Rennes - Hospital Pontchaillou
Rennes, 35033
Hopital Charles Nicolle Chu Rouen Hospital de Bois-Guillaume
Rouen, 76031
Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene Gauducheau
Saint-Herblain, 44800
Institut de Cancerologie de Strasbourg
Strasbourg, 67200
Chu Toulouse Hopital Rangueil
Toulouse, 31059
Institut Gustave Roussy
Villejuif, 94805
United States14 sites
Virginia Cancer Specialists, Pc
Arlington, Virginia, 22205
Texas Oncology
Austin, Texas, 78745
Maryland Oncology Hematology, P.A.
Columbia, Maryland, 21044
Baylor Scott and White Research Institute
Dallas, Texas, 75246
Rocky Mountain Cancer Center
Denver, Colorado, 80218
City of Hope National Medical Center
Duarte, California, 91010
Ochsner Clinic
New Orleans, Louisiana, 70121
Blue Ridge Cancer Care
Roanoke, Virginia, 24014
Mayo Clinic
Rochester, Minnesota, 55905
UC Davis Comprehensive Cancer Center
Sacramento, California, 95817
Sansum Clinic
Santa Barbara, California, 93105
Renovatio Clinical Consultants Llc
The Woodlands, Texas, 77380
The University of Arizona Cancer Center
Tucson, Arizona, 85724
Texas Oncology-Wichita Falls Texoma Cancer Center
Wichita Falls, Texas, 76310
Italy12 sites
Fondazione Irccs Ca Granda Ospedale Maggiore
Milan, 20122
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milan, 20162
Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano
Milan, 20133
European Institute of Oncology
Milan, 20141
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milan, 20162
University Di Cagliari-Presidio Policlinico Monserrato
Monserrato, 09042
Azienda Ospedaliera Universitaria University Degli Studi Della Campania Luigi Vanvitelli
Naples, 80131
Iov - Istituto Oncologico Veneto Irccs
Padova, 35128
Azienda Ospedaliero Universitaria Pisana
Pisa, 56126
Ospedale Degli Infermi
Rimini, 47923
I.R.C.C.S. Casa Sollievo Della Sofferenza
San Giovanni Rotondo, 71013
Azienda Ospedaliero Universitaria Ospedali Riuniti
Torrette, 60020
United Kingdom12 sites
Royal Sussex County Hospital
Brighton, BN2 5BE
Addenbrooke'S Hospital
Cambridge, CB2 0QQ
Royal Surrey County Hospital
Guildford, GU2 7XX
Castle Hill Hospital
Hull, HU16 5JQ
Leeds Teaching Hospital
Leeds, LS 9 7TF
Royal Free London Nhs Foundation Trust
London, NW3 2QG
The Royal Marsden Nhs Foundation Trust - Chelsea
London, SW3 6JJ
The Christie Nhs Foundation Trust Uk
Manchester, M20 4BV
Churchill Hospital
Oxford, OX3 7LE
Royal Preston Hospital
Preston, PR2 9HT
The Royal Marsden Nhs Foundation Trust - Sutton
Sutton, SM2 5PT
Royal Cornwall Hospital Truro Sunrise Centre
Truro, TR1 3LQ
Spain8 sites
Complejo Hospitalario Universitario A Coruna
A Coruña, 15006
Hospital General Universitario Vall D Hebron
Barcelona, 08035
Hospital Clinic de Barcelona
Barcelona, 08036
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario de La Paz
Madrid, 28046
Son Espases University Hospital
Palma de Mallorca, 07120
Hospital Universitario Virgen Del Rocio
Seville, 41013
Hospital Universitario Miguel Servet
Zaragoza, 50009
Japan7 sites
National Cancer Center Hospital
Chūōku, 104-0045
Kyushu University Hospital
Fukuoka, 812-8582
Saitama Medical University International Medical Center
Hidaka-shi, 350-1298
Aichi Cancer Center Hospital
Nagoya, 464-8681
Osaka International Cancer Institute
Osaka, 541-8567
Tohoku University Hospital
Sendai, 980-8574
Center Hospital of the National Center For Global Health and Medicine
Shinjuku-ku, 162-8655
Australia3 sites
Flinders Medical Centre
Bedford Park, South Australia, 5042
Monash Medical Centre Clayton
Clayton, Victoria, 03168
Princess Alexandra Hospital Australia
Woolloongabba, Queensland, 04102
Germany3 sites
Universitatsklinikum Bonn Aoer
Bonn, 53127
University Clinic Carl Gustav Carus Technical University Dresden
Dresden, 01307
Asklepios Klinik Altona
Hamburg, 22763
Sweden3 sites
Sahlgrenska University Hospital
Gothenburg, 413 45
Skaenes Universitetssjukhus Lund
Lund, 22185
Stockholm South General Hospital Sodersjukhuset
Stockholm, 118 83
Belgium2 sites
Zna Middelheim
Antwerp, 02020
Ulb Hospital Erasme
Brussels, 01070
Denmark2 sites
Herlev Og Gentofte Hospital
Herlev, 02730
Vejle Hospital
Vejle, 07100
Norway2 sites
Haukeland University Hospital
Bergen, 05021
Oslo Universitetssykehus
Oslo, 00450
Puerto Rico1 site
Panoncology Trials Pan American Center For Oncology Trials, Llc
San Juan, 00935
About this study
Official title: A Phase 3 Global, Multicenter, Double-Blind Randomized Study of Carboplatin-Paclitaxel With INCMGA00012 or Placebo in Participants With Inoperable Locally Recurrent or Metastatic Squamous Cell Carcinoma of the Anal Canal Not Previously Treated With Systemic Chemotherapy (POD1UM-303/InterAACT 2)
This study is a Phase 3 global, multicenter, placebo-controlled double-blind randomized study that will enroll participants with inoperable locally recurrent or metastatic SCAC not previously treated with systemic chemotherapy.
- Being tested
- carboplatin, paclitaxel, retifanlimab
- Keywords
- Squamous cell carcinoma, carboplatin, paclitaxel, PD-1 Inhibitor, Anal Cancer, SCAC
- Medical subject headings
- Carcinoma, Squamous Cell, Anus Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carboplatinDrug
carboplatin will be administered intravenous on Day 1 of each 28 day cycle
paclitaxelDrug
paclitaxel will be administered intravenous on Days 1,8, and 15 of each 28 day cycle
retifanlimabDrug
Also called INCMGA00012
retifanlimab will be administered intravenous on Day 1 of each 28 day cycle
| Study group | Role | What they receive |
|---|---|---|
| Group A : carboplatin+paclitaxel+placebo | Placebo comparator | Participants will receive carboplatin on Day 1,paclitaxel on Day1,8, 15, and placebo on Day 1 of each 28 day cycle Receives: Drug: carboplatin; Drug: paclitaxel |
| Group B : carboplatin+paclitaxel+retifanlimab | Experimental | Participants will receive carboplatin on Day 1,paclitaxel on Day1,8, 15, and retifanlimab on Day 1 of each 28 day cycle Receives: Drug: carboplatin; Drug: paclitaxel; Drug: retifanlimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS)
PFS was defined as the time from the date of randomization to the date of the first documented disease progression (PD), according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by blinded independent central review committee (BICR), or death due to any cause, whichever occurred first. PD: progression of a target or non-target lesion or presence of a new lesion.
Measured: up to 33.9 months
Secondary outcomes (12)
Overall Survival
Overall survival was defined as the time from the date of randomization until the date of death due to any cause.
Measured: up to 56.5 months
Objective Response Rate (ORR)
ORR was defined as the percentage of participants with a confirmed CR or PR at any post-Baseline visit before the first PD or new anticancer therapy, according to RECIST v1.1 as determined by BICR. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
Measured: up to 445 days
Duration of Response (DOR)
DOR was defined as the time from the first documented confirmed response (CR or PR) determined by BICR to the time of first documented disease progression per RECIST v1.1 or death due to any cause. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion.
Measured: up to 32.1 months
Disease Control Rate (DCR)
DCR was defined as the percentage of participants maintaining either a confirmed overall response of CR or PR or stable disease (SD) at any post-Baseline visit before the first PD or new anticancer therapy, according to RECIST v1.1 as determined by BICR. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.
Measured: up to 445 days
Number of Participants With Any Treatment-emergent Adverse Event (TEAE ) During the Randomized Period
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. TEAEs were defined as any AEs either reported for the first time or the worsening of a pre-existing events after the first dose of study treatment and within 90 days of the last administration of retifanlimab/placebo, or within 30 days of the last chemotherapy. AEs that occurred after new anticancer therapy were be excluded.
Measured: up to 535 days
Number of Participants With Any TEAE Leading to Discontinuation of Study Drug During the Randomized Period
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. TEAEs were defined as any AEs either reported for the first time or the worsening of a pre-existing events after the first dose of study treatment and within 90 days of the last administration of retifanlimab/placebo, or within 30 days of the last chemotherapy. AEs that occurred after new anticancer therapy were be excluded.
Measured: up to 535 days
Number of Participants With Any TEAE During the Open-label Monotherapy Period
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. TEAEs were defined as any AEs either reported for the first time or the worsening of a pre-existing events after the first dose of study treatment and within 90 days of the last administration of retifanlimab/placebo. AEs that occurred after new anticancer therapy were be excluded.
Measured: up 463 days
Number of Participants With Any TEAE Leading to Discontinuation of Study Drug During the Open-label Monotherapy Period
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. TEAEs were defined as any AEs either reported for the first time or the worsening of a pre-existing events after the first dose of study treatment and within 90 days of the last administration of retifanlimab/placebo. AEs that occurred after new anticancer therapy were be excluded.
Measured: up 463 days
Cmax of Retifanlimab at Steady State When Administered With Carboplatin-paclitaxel
Cmax was defined as the maximum observed plasma concentration of retifanlimab.
Measured: preinfusion on Day 1 of Cycles 1, 2, 4, 6, 8, and 12; immediately after infusion on Day 1 of Cycles 1 and 4
Cmin of Retifanlimab at Steady State When Administered With Carboplatin-paclitaxel
Cmin was defined as the minimum observed plasma concentration of retifanlimab.
Measured: preinfusion on Day 1 of Cycles 1, 2, 4, 6, 8, and 12; immediately after infusion on Day 1 of Cycles 1 and 4
Tmax of Retifanlimab at Steady State When Administered With Carboplatin-paclitaxel
tmax was defined as the time to the maximum serum concentration of retifanlimab.
Measured: preinfusion on Day 1 of Cycles 1, 2, 4, 6, 8, and 12; immediately after infusion on Day 1 of Cycles 1 and 4
AUC of Retifanlimab at Steady State When Administered With Carboplatin-paclitaxel
AUC was defined as the area under the serum concentration versus time curve.
Measured: preinfusion on Day 1 of Cycles 1, 2, 4, 6, 8, and 12; immediately after infusion on Day 1 of Cycles 1 and 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2020
- Study start9 Nov 2020
- Primary completion15 Apr 2024
- Study completion26 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Squamous Cell Carcinoma of the Anal CanalStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 308 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04472429
- Sponsor's protocol ID
- INCMGA 0012-303
- Other IDs
- 2024-512331-72-00, 2020-000826-24
- Status last verified
- Sep 2026
- First submitted
- 13 Jul 2020
- Last updated
- 25 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
- Expanded access
- Available
Publications
Rao S, Samalin-Scalzi E, Evesque L, Ben Abdelghani M, Morano F, Roy A, Dahan L, Tamberi S, Dhadda AS, Saunders MP, Casanova N, Guimbaud R, Lievre A, Maurel J, Fakih M, Tian C, Harrison J, Jones MM, Cornfeld M, Spano JP, Rochefort P; POD1UM-303/InterAACT-2 study investigators. Retifanlimab with carboplatin and paclitaxel for locally recurrent or metastatic squamous cell carcinoma of the anal canal (POD1UM-303/InterAACT-2): a global, phase 3 randomised controlled trial. Lancet. 2025 Jun 14;405(10495):2144-2152. doi: 10.1016/S0140-6736(25)00631-2.
PubMed 40517007Rao S, Jones M, Bowman J, Tian C, Spano JP. POD1UM-303/InterAACT 2: A phase III, global, randomized, double-blind study of retifanlimab or placebo plus carboplatin-paclitaxel in patients with locally advanced or metastatic squamous cell anal carcinoma. Front Oncol. 2022 Aug 24;12:935383. doi: 10.3389/fonc.2022.935383. eCollection 2022.
PubMed 36091159
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Global, Multicenter, Double-Blind Randomized Study of Carboplatin-Paclitaxel With INCMGA00012 or Placebo in Participants With Inoperable Locally Recurrent or Metastatic Squamous Cell Carcinoma of the Anal Canal Not Previously Treated With Systemic Chemotherapy (POD1UM-303/InterAACT 2)
- ClinicalTrials.gov ID
- NCT04472429
- Acronym / sponsor ID
- INCMGA 0012-303
- Keywords
- Squamous cell carcinoma, carboplatin, paclitaxel, PD-1 Inhibitor, Anal Cancer, SCAC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 308 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 9 Nov 2020 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 26 Sep 2025 (actual)
- First posted
- 15 Jul 2020 (actual)
- Results
- Posted 23 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a Phase 3 global, multicenter, placebo-controlled double-blind randomized study that will enroll participants with inoperable locally recurrent or metastatic SCAC not previously treated with systemic chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A : carboplatin+paclitaxel+placebo | Placebo comparator | Drug: carboplatin, Drug: paclitaxelParticipants will receive carboplatin on Day 1,paclitaxel on Day1,8, 15, and placebo on Day 1 of each 28 day cycle |
| Group B : carboplatin+paclitaxel+retifanlimab | Experimental | Drug: carboplatin, Drug: paclitaxel, Drug: retifanlimabParticipants will receive carboplatin on Day 1,paclitaxel on Day1,8, 15, and retifanlimab on Day 1 of each 28 day cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Able to comprehend and willing to sign a written ICF for the study.
Key exclusion criteria (14 listed)
- Has received prior PD-(L)1 directed therapy
- Has received prior radiotherapy with or without radiosensitizing chemotherapy within 28 days of Cycle 1 Day 1 except for palliative radiation (30 Gy or less) which is restricted for 14 days of Cycle 1 Day 1 (note: all toxicities associated should have resolved to Grade ≤ 1).
- Participants with laboratory outside of the protocol defined ranges.
- History of second malignancy within 3 years (with exceptions).
- Clinically significant pulmonary, cardiac, gastrointestinal or autoimmune disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| carboplatincarboplatin will be administered intravenous on Day 1 of each 28 day cycle | Drug | Group A : carboplatin+paclitaxel+placebo, Group B : carboplatin+paclitaxel+retifanlimab |
| paclitaxelpaclitaxel will be administered intravenous on Days 1,8, and 15 of each 28 day cycle | Drug | Group A : carboplatin+paclitaxel+placebo, Group B : carboplatin+paclitaxel+retifanlimab |
| retifanlimabAlso: INCMGA00012retifanlimab will be administered intravenous on Day 1 of each 28 day cycle | Drug | Group B : carboplatin+paclitaxel+retifanlimab |
Primary outcome
Progression-free Survival (PFS)
Time frame: up to 33.9 months
PFS was defined as the time from the date of randomization to the date of the first documented disease progression (PD), according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by blinded independent central review committee (BICR), or death due to any cause, whichever occurred first. PD: progression of a target or non-target lesion or presence of a new lesion.
12 secondary outcomes
Overall Survival
Time frame: up to 56.5 months
Objective Response Rate (ORR)
Time frame: up to 445 days
Duration of Response (DOR)
Time frame: up to 32.1 months
Disease Control Rate (DCR)
Time frame: up to 445 days
Number of Participants With Any Treatment-emergent Adverse Event (TEAE ) During the Randomized Period
Time frame: up to 535 days
Number of Participants With Any TEAE Leading to Discontinuation of Study Drug During the Randomized Period
Time frame: up to 535 days
Number of Participants With Any TEAE During the Open-label Monotherapy Period
Time frame: up 463 days
Number of Participants With Any TEAE Leading to Discontinuation of Study Drug During the Open-label Monotherapy Period
Time frame: up 463 days
Cmax of Retifanlimab at Steady State When Administered With Carboplatin-paclitaxel
Time frame: preinfusion on Day 1 of Cycles 1, 2, 4, 6, 8, and 12; immediately after infusion on Day 1 of Cycles 1 and 4
Cmin of Retifanlimab at Steady State When Administered With Carboplatin-paclitaxel
Time frame: preinfusion on Day 1 of Cycles 1, 2, 4, 6, 8, and 12; immediately after infusion on Day 1 of Cycles 1 and 4
Tmax of Retifanlimab at Steady State When Administered With Carboplatin-paclitaxel
Time frame: preinfusion on Day 1 of Cycles 1, 2, 4, 6, 8, and 12; immediately after infusion on Day 1 of Cycles 1 and 4
AUC of Retifanlimab at Steady State When Administered With Carboplatin-paclitaxel
Time frame: preinfusion on Day 1 of Cycles 1, 2, 4, 6, 8, and 12; immediately after infusion on Day 1 of Cycles 1 and 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40517007Rao S, Samalin-Scalzi E, Evesque L, Ben Abdelghani M, Morano F, Roy A, Dahan L, Tamberi S, Dhadda AS, Saunders MP, Casanova N, Guimbaud R, Lievre A, Maurel J, Fakih M, Tian C, Harrison J, Jones MM, Cornfeld M, Spano JP, Rochefort P; POD1UM-303/InterAACT-2 study investigators. Retifanlimab with carboplatin and paclitaxel for locally recurrent or metastatic squamous cell carcinoma of the anal canal (POD1UM-303/InterAACT-2): a global, phase 3 randomised controlled trial. Lancet. 2025 Jun 14;405(10495):2144-2152. doi: 10.1016/S0140-6736(25)00631-2.
- Derived from this study: PubMed 36091159Rao S, Jones M, Bowman J, Tian C, Spano JP. POD1UM-303/InterAACT 2: A phase III, global, randomized, double-blind study of retifanlimab or placebo plus carboplatin-paclitaxel in patients with locally advanced or metastatic squamous cell anal carcinoma. Front Oncol. 2022 Aug 24;12:935383. doi: 10.3389/fonc.2022.935383. eCollection 2022.
- Individual participant dataSharing planned: Yes. Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
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Study of Safety and Tolerability of BCA101 Monotherapy and in Combination Therapy in Patients With EGFR-driven Advanced Solid Tumors
Head and Neck Squamous Cell Carcinoma, Squamous Cell Carcinoma of Anal Canal
Active, not recruitingPhase 2
Nivolumab With or Without Ipilimumab in Treating Patients With Refractory Metastatic Anal Canal Cancer
Anal Canal Squamous Cell Carcinoma, Metastatic Anal Canal Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
84 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing carboplatin, paclitaxel and retifanlimab in people with Squamous Cell Carcinoma of the Anal Canal, run by Incyte Corporation at 84 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 84 sites in France, United States, Italy, United Kingdom, Spain and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (PFS) (time frame: up to 33.9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04472429, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.